On October 15, 2026 Crescent Biopharma, Inc. ("Crescent" or the "Company") (Nasdaq: CBIO), a clinical-stage biotechnology company dedicated to rapidly advancing the next wave of therapies for cancer patients, reported clinical pipeline momentum, including enrolling patients in cohorts combining CR-001, a PD-1 x VEGF bispecific antibody, plus standard of care chemotherapy regimens in its global Phase 1/2 ASCEND trial, as well as the initiation of additional antibody-drug conjugate (ADC) combination studies with CR-001.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our team’s outstanding execution has enabled us to rapidly advance three programs into the clinic in 2026 and make significant progress in developing next-generation IO, ADC and combination therapies. Together with our partner, Kelun-Biotech, we have achieved seven IND clearances to date, and by mid-2027, we expect more than 2,000 patients to have been dosed across our portfolio. We remain focused on generating meaningful clinical data and expect to begin sharing results in the first quarter of 2027, including data from ASCEND, which is enrolling first-line NSCLC patients globally, including in the United States and Europe. We believe these data can support the initiation of the first of multiple Phase 3 studies of CR-001 in early 2028," said Joshua Brumm, chief executive officer of Crescent.

"Our partnership with Kelun-Biotech brings together two companies with a shared commitment to accelerating the development of potentially transformative therapies for people living with cancer. Multiple combination trials of CR-001 and sac-TMT are already underway in China, with additional ADC combination studies planned. In 2026, we established the foundation for the next phase of Crescent’s growth: delivering multiple important clinical readouts across our IO and ADC portfolio, beginning early next year," said Mr. Brumm.

Clinical Execution Progress in ASCEND, a Global Phase 1/2 Trial of CR-001

On track to report initial monotherapy data from ASCEND in Q1 2027

Crescent has completed dose escalation in the global Phase 1/2 ASCEND trial of CR-001, its investigational PD-1 x VEGF bispecific, developed in collaboration with Paragon Labs, with patients enrolled across several tumor types at clinical sites in the United States, Europe and South Korea.

The Company plans to report initial monotherapy data from ASCEND in the first quarter of 2027, including:
Preliminary antitumor response as measured by overall response rate (ORR) from a first-line NSCLC cohort of up to 12 patients.
Safety, tolerability, pharmacokinetic and pharmacodynamic data from more than 125 treatment-naïve and previously-treated patients across multiple solid tumor types.

Enrolling patients in standard of care chemotherapy combination cohorts

Enrollment has commenced in the standard of care chemotherapy combination expansion cohorts of ASCEND. Hundreds of participants are expected to enroll in this part of the study with various tumor types and chemotherapy regimens being evaluated, including:
First-line (1L) NSCLC: CR-001 + paclitaxel and carboplatin (squamous) or pemetrexed and carboplatin (non-squamous)
1L mismatch repair proficient (pMMR) / microsatellite stable (MSS) colorectal cancer (CRC): CR-001 + mFOLFOX6
Third-line (3L) CRC: CR-001 + trifluridine and tipiracil
1L biliary tract cancer: CR-001 + gemcitabine and cisplatin
1L pMMR endometrial cancer: CR-001 + carboplatin and paclitaxel
1L programmed cell death ligand 1 (PD-L1)-expressing gastric/gastroesophageal junction (GEJ) cancer: CR-001 + capecitabine and oxaliplatin
Second-line (2L) PD-L1-expressing gastric/GEJ cancer: CR-001 + paclitaxel
Crescent plans to report initial data from the chemotherapy combination cohorts in mid-2027 (Q2/Q3).

Data from these cohorts, along with monotherapy data from ASCEND, will inform future clinical development for CR-001. Pending results and further interactions with regulators, Crescent plans to initiate the first of multiple Phase 3 trials of CR-001 in early 2028.

Trial in progress posters on the ASCEND study design will be presented during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2026 Congress being held October 23-27, 2026 in Madrid, Spain and at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2026 Annual Meeting being held November 4-8, 2026 in Phoenix, Arizona.

Multiple Studies Evaluating CR-001 in Combination with Novel ADCs

Under a collaboration agreement, Crescent granted Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., ("Kelun-Biotech") exclusive rights to research, develop, and commercialize CR-001 (also known as SKB118) in Greater China. Both Kelun-Biotech and Crescent have rights to independently develop CR-001 in combinations, including with their respective ADC pipelines. Kelun-Biotech is conducting multiple trials in China evaluating CR-001 in combination with sacituzumab tirumotecan (sac-TMT), its TROP2-directed ADC, and additional ADC combination studies are planned.
A Phase 2 trial of CR-001 (SKB118) and sac-TMT in participants with locally advanced or metastatic NSCLC is ongoing with initial data expected in mid-2027 (Q2/Q3).
A Phase 2 trial of sac-TMT in combination with CR-001 (SKB118) is now enrolling participants with advanced solid tumors.
A Phase 2 trial of sac-TMT in combination with CR-001 (SKB118) is initiating in epidermal growth factor receptor (EGFR)-mutant locally advanced or metastatic non-squamous NSCLC who have failed EGFR tyrosine kinase inhibitor (EGFR-TKI) therapy.
A Phase 1/2 trial of CR-001(SKB118) in combination with CR-003 (also known as SKB105), an integrin-beta 6 (ITGB6)-directed ADC, is expected to commence in the first half of 2027.

Advancing a Differentiated ADC Pipeline

Earlier this month, CR-002, Crescent’s topoisomerase inhibitor ADC targeting PD-L1, internally developed in collaboration with Paragon Labs, received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration. Crescent is on track to initiate the global Phase 1/2 APOLLO trial this quarter in patients with advanced solid tumors, including NSCLC, head and neck squamous cell carcinoma (HNSCC), and various gastrointestinal and gynecological tumors. Initial data are expected in the second half of 2027.

Kelun-Biotech granted Crescent exclusive rights to research, develop, and commercialize CR-003 (SKB105), an ITGB6-targeted ADC, in the United States, Europe and all markets outside of Greater China. A Phase 1/2 trial of CR-003 (SKB105) in participants with advanced solid tumors conducted by Kelun-Biotech in China is ongoing and proof-of-concept data are expected in the first quarter of 2027. Crescent plans to leverage data generated in China to support the global clinical development of CR-003 (SKB105).

(Press release, Crescent Biopharma, OCT 15, 2026, View Source [SID1234673484])

On October 15, 2026 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, reported that efficacy results from a subset of patients treated with iopofosine I 131 immediately post-Bruton Tyrosine Kinase inhibitor (BTKi) therapy in the company’s Phase 2b CLOVER WaM clinical trial of iopofosine I 131 to treat relapsed or refractory (r/r) Waldenström macroglobulinemia (WM) were presented today at the International Workshop for Waldenström Macroglobulinemia (IWWM) taking place October 14 to October 16, 2026, in Palm Springs, California.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The poster highlighted data from a subgroup (n=24) of patients treated with a BTKi immediately prior to iopofosine I 131 from the CLOVER WaM trial in WM. This subgroup analysis is derived from the CLOVER WaM clinical trial 12-month follow-up data set previously reported.

"These compelling data further strengthen the growing body of evidence supporting the potential of iopofosine I 131 to address a critical unmet need and offers something WM patients rarely get after BTK inhibitors: deep, durable responses from a short, fixed course of treatment. Because its targeted radiation works independently of the BTK pathway and other pathways currently targeted or attempting to be targeted, we believe it has the potential to remain effective as patients become refractory to today’s targeted therapies, and those still to come," said Jarrod Longcor, chief operating officer of Cellectar Biosciences. "Patients in the immediate post-BTKi setting often face limited treatment options and increasingly refractory disease, making the robust response rates, durable clinical benefit, and favorable tolerability profile observed in this analysis especially encouraging. With Breakthrough Therapy Designation, a mature and expanding CLOVER WaM dataset, and plans underway to dose patients in our confirmatory clinical trial in early 2027, we believe iopofosine I 131 is well positioned to become a meaningful new treatment option for these patients, and we remain focused on advancing the program toward potential regulatory approval."

Summary of Results in Subgroup Immediately post-BTKi treatment (n=24)
The patients included in this subset analysis were enrolled in the CLOVER WaM clinical trial and were treated with iopofosine I 131 immediately after receiving a regimen containing BTKi. Seventy-five percent were BTKi refractory and more than 54% had received multiple BTKi therapies. Patients had a median of three prior lines of therapy (range 2-7) with 17% being TP53 mutated and 29% being MYD88 wild type, both of which confer greater resistance and rapid progression. Key findings included:

Overall Response Rate (ORR): 87.5%
Major Response Rate (MRR): 79.2%
Median Duration of Response (DoR): 16.0 months
Treatment Free Survival (TFS): 19.1 months
Clinical Benefit Rate (CBR): 100%
Safety: Treatment emergent adverse events (TEAE) occurred in less than 10% of patients, with the only Grade 3 or higher TEAE being cytopenias
Cellectar is advancing plans to dose the first patients in the confirmatory Phase 3 randomized clinical trial in a post-first line, post-BTKi population. The registration-directed trial is expected to evaluate progression-free survival (PFS) as the primary endpoint, consistent with regulatory guidance.

The company is also preparing to submit a New Drug Application for accelerated approval with the U.S. Food and Drug Administration (FDA) in the first half of 2027, supported by the strength and maturity of the CLOVER WaM dataset.

About Accelerated Approval and Confirmatory Study Initiation
The CLOVER WaM dataset incorporates key elements aligned with regulatory expectations for accelerated approval as requested by the FDA, including:

Use of surrogate endpoints (MRR supported by DoR) reasonably likely to predict clinical benefit
Demonstration of durable responses in a high unmet need population
Completion of ≥12-month follow-up across all patients

(Press release, Cellectar Biosciences, OCT 15, 2026, View Source [SID1234673483])

On October 15, 2026 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing antibody drug conjugates (ADCs) with a novel RNA splicing disrupting payload, reported a new CEO Corner segment featuring President and Chief Executive Officer Abizer Gaslightwala discussing the Company’s differentiated ADC payload strategy, recent external validation and the execution priorities supporting AKTX-101’s advancement toward planned Phase 1 clinical development in mid-2027.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

At the center of the discussion is Akari’s belief that ADC payload differentiation will become increasingly important as more cancer patients receive ADCs as front-line therapies and develop resistance to the current ADC payload classes leaving limited subsequent therapy options. Mr. Gaslightwala discusses emerging clinical data presented at major medical conferences that sequential treatment of ADCs utilizing the same payload class do not provide benefit after treatment relapse. This is a significant growing unmet need and is an exclusive opportunity for Akari with its novel ADC payload that current and most future ADCs will not be able to access.

Akari is pursuing this exclusive opportunity using its PH1 payload, a novel spliceosome-modulating payload, which is designed to disrupt RNA splicing in cancer cells through a mechanism distinct from commonly used ADC payload classes.

Mr. Gaslightwala also describes recent external engagements and presentations at partnering and industry conferences in the US and China, where there was significant interest in Akari’s ADC payload and its differentiated approach.

"It was important for us to gauge interest and excitement in our novel payload technology and its application to ADC therapies in areas of growing unmet needs like ADC refractory patients, and I left the conferences even more convicted in our technology, strategy, and execution as a company," said Mr. Gaslightwala. "Across recent partner discussions and industry engagement, our novel PH1 payload generated meaningful interest and reinforced our belief that differentiated payloads can play an increasingly important role as ADC therapies continue to evolve."

Mr. Gaslightwala also points to recent industry transactions involving novel ADC payload technologies, including Novartis’s agreement to acquire Myricx Bio and Genentech’s collaboration with DualityBio, as additional evidence of strategic interest by Big Pharma companies in acquiring and developing next-generation payload approaches.

With this backdrop, Akari’s focus is now on execution.

The Company continues to advance AKTX-101 through IND-enabling toxicology and safety studies, large-scale GMP manufacturing, and Phase 1 planning, with the goal of initiating clinical development in mid-2027. In parallel, Akari is also continuing discussions with potential strategic partners around PH1 and the broader potential of its payload platform to create a broader pipeline of ADCs using this novel technology

"Our focus now is execution," said Mr. Gaslightwala. "We are advancing the work required to move AKTX-101 into the clinic while continuing to explore the broader potential of PH1. We believe successful execution could create multiple opportunities for value creation through AKTX-101, potential licensing of our payload technology, and new concepts such as dual-payload approaches based on PH1."

"We believe Akari has built a differentiated scientific foundation," Mr. Gaslightwala added. "The next step is to translate that foundation through disciplined execution and demonstrate the potential of this technology in the clinic."

The CEO Corner segment is now available here.

(Press release, Akari Therapeutics, OCT 15, 2026, View Source [SID1234673482])

On October 15, 2026 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) (Actinium or the Company), a pioneer in differentiated targeted radiotherapies with the potential to transform cancer treatment, reported that an oral presentation with early results from the first-in-human Phase 1 study of ATNM-400 in metastatic castration-resistant prostate cancer (mCRPC) will be presented at the 39th Annual Congress of the European Association of Nuclear Medicine (EANM), October 17–21, 2026, in Vienna, Austria.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The oral presentation will highlight the ongoing first-in-human Phase 1 dose-escalation study of ATNM-400 in mCRPC. ATNM-400 is a first-in-class Actinium-225 (²²⁵Ac) antibody radioconjugate targeting a non-PSMA antigen implicated in tumor survival and treatment resistance. The study will characterize the safety, biodistribution, and dosimetry of Zirconium-89-labeled ATNM-400. Serial PET imaging will assess its tumor uptake, distribution, and clearance, with dosimetry estimates informing therapeutic ²²⁵Ac-ATNM-400 dosing.

"These first clinical data from ATNM-400 mark an important milestone for Actinium and for prostate cancer treatment beyond PSMA," said Sandesh Seth, Actinium’s Chairman and CEO. "As a first-in-class radiotherapeutic targeting an antigen implicated in tumor survival and treatment resistance, ATNM-400 has the potential to serve the broad mCRPC population, including patients with PSMA-low or PSMA-negative disease and those who do not respond to or progress after PSMA-directed therapies. These initial findings mark an important milestone for ATNM-400 and our Actinium-225 development program."

ATNM-400 EANM 2026 Presentation Details

Abstract Title: First-In-Human Phase 1 Study of ATNM-400, Actinium-225 Antibody Radioconjugate, in Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Abstract Number: OP-525
Presentation Type: Oral presentation
Session: 1111 — Theranostics Track: Prostate Cancer Therapy II
Session Date & Time: Monday, October 19, 2026, 4:45–6:15 p.m. CEST | Vienna, Austria
Location: Hall G1

(Press release, Actinium Pharmaceuticals, OCT 15, 2026, View Source [SID1234673481])

On October 15, 2026 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) ("Actinium" or the "Company"), a pioneer in the development of targeted radiotherapies, reported the appointment of Matt David, M.D., as Chief Financial Officer. Dr. David will lead the Company’s finance, accounting, capital markets and investor relations functions and will also serve as the Company’s principal financial officer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr. David brings more than two decades of experience across biopharmaceutical operating leadership, healthcare investment banking and equity research. He joins Actinium from CorMedix Inc. (Nasdaq: CRMD), where he most recently served as Executive Vice President and Chief Business Officer. He joined CorMedix in 2020 as Executive Vice President and Chief Financial Officer. During his tenure, CorMedix received U.S. Food and Drug Administration approval of DefenCath in 2023, launched the product commercially in 2024, and in 2025 acquired a commercial anti-infectives company, becoming a diversified, commercial-stage specialty pharmaceutical company.

Sandesh Seth, Actinium’s Chairman and CEO, said, "Matt is an exceptional addition to our leadership team. He has been a public company CFO, an interim CEO and a CBO, and he has helped guide a company from late-stage development through FDA approval, commercial launch and a transformational acquisition. Combined with his medical background and his years advising and financing biopharmaceutical companies on Wall Street, Matt brings a rare blend of scientific fluency, capital markets expertise and strategic judgment. As we advance ATNM-400, Actimab-A, Iomab-ACT and build on our leadership in radiotherapies, his experience will be invaluable in strengthening our financial operations, engaging with the financial community and helping to guide the company strategically."

Dr. David said, "Actinium has built a differentiated targeted radiotherapy platform at a time when radiopharmaceuticals have become one of the most dynamic areas in oncology drug development. With a first-in-human study of ATNM-400 underway, a clinically validated Actimab-A program and deep expertise in actinium-225, I believe the Company has multiple significant value drivers ahead. I am excited to join the leadership team and look forward to helping position Actinium to execute on its strategy and deliver value for patients and shareholders."

Prior to his roles at CorMedix, Dr. David served as Head of Strategy at Ovid Therapeutics Inc. (Nasdaq: OVID). Before moving into industry, he spent more than a decade in healthcare investment banking, including at BofA Merrill Lynch, Thomas Weisel Partners and Piper Jaffray, where he advised biopharmaceutical companies on financings and strategic transactions, and at Lehman Brothers as an equity research associate covering the pharmaceutical sector. Dr. David received his M.D. from NYU School of Medicine and was a surgery resident at Beth Israel Hospital. He received his undergraduate degree in Chemistry from Dartmouth College.

(Press release, Actinium Pharmaceuticals, OCT 15, 2026, View Source [SID1234673480])